A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety ā¦ (NCT03789617) | Clinical Trial Compass
UnknownPhase 1/2
A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies
South Korea72 participantsStarted 2018-12-14
Plain-language summary
The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part 3\&5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP + lymphodepletion on solid tumors
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. At least 19 years of age
ā. Patients with lymphomas or solid tumors who have been found to be positive for EBV encoded RNA (EBER) by in situ hybridization (ISH) (previous test results may be used as evidence if available)
ā. Part 1: Histologically or cytologically confirmed lymphoma or solid tumor
ā. Part 2: Histologically or cytologically confirmed solid tumor
ā. Part 3: Patients who have been diagnosed with histologically confirmed extranodal NK/T-cell lymphoma (ENKL) according to WHO classification
ā. Parts 4 and 5: Patients with histologically confirmed gastric cancer or esophageal adenocarcinoma
ā. Patients who have given written consent to voluntarily participate in the epitope screening
Exclusion criteria
ā. Patients with aggressive NK cell leukemia
ā. Patients with hemophagocytic lymphohistiocytosis (HLH)
What they're measuring
1
Confirmed objective response rate (confirmed ORR) [assessed by IRRC]
ā. Persons who have previously received a solid organ transplant
ā. Persons who have been diagnosed with a malignant tumor other than the target disease in the past 5 years (treated basal cell carcinoma, squamous epithelial cell carcinoma, and non-invasive cervical cancer do not necessitate exclusion)
ā. Patients in whom a tuberculosis infection was confirmed in the 1 year prior to screening for the present study (However, patients who have been determined to be cured after treatment may be enrolled.)
ā. Patients who test positive for anti-HIV antibodies
ā. Patients deemed unsuitable to participate in the clinical trial by an investigator based on active infection (HBV, HCV) test results
ā. Persons who have been found to be capable of production in the epitope screening test